EMEA Article 58 to speed availability in Africa’s Meningitis Belt, Middle-East and North Africa

GlaxoSmithKline announced today the submission of a regulatory file to European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix™ (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C). In clinical trials including countries in Africaand Asia, the conjugate meningococcal vaccine has demonstrated a good safety profile and immunogenicity against meningococcal meningitis caused by Neisseria meningitidis serogroups A and C in addition to five other major childhood diseases. Under Article 58, the EMEA, in cooperation with the World Health Organization (WHO), gives a scientific opinion on the efficacy, quality and safety of medicinal products intended for use exclusively outside the European Union.


“GSK’s long-standing commitment to the developing world is reflected in the development of Globorix™, a vaccine designed specifically to meeta pressing public health threat in Africa,” said Jean Stéphenne, President of GlaxoSmithKline Biologicals. “Using the innovative Article 58 mechanism will expedite the availability of Globorix™ to those in greatest need while ensuring it meets the world’s most stringent standards for safety and efficacy. This vaccine candidate could be available as early as 2008 and has the potential to break the cycle of meningitis epidemics in Africa. It will provide babies with protection against 7 diseases in a combination vaccine and, administered in the classical Expanded Programme on Immunisation, it will help to simplify logistics and costs.”


In 2000 the WHO and leading public health experts called for the development of conjugate vaccines in order to shift meningitis control away from expensive last-minute outbreak immunization campaigns towards a more sustainable and long-term prevention strategy. Until today no combined conjugate meningococcal vaccine has been available to protect infants in Africaagainst the disease.


The current meningitis control strategy relies on reactive mass immunization campaigns using polysaccharide vaccines. While these campaigns are estimated to have saved 70% of lives in epidemics, this older type of vaccine has significant drawbacks. Polysaccharide vaccines do not offer protection to infants and in older children and adults they only protect for 3-5 years, leaving them vulnerable to future epidemics. Polysaccharide vaccines also do not address endemic meningitis1.


“There is an urgent need for an improved meningococcal vaccine,” said Dr. A. Hodgson, Director, Navrongo Health Research Center, Ghana. “Children are at great risk during the first two years of life and currently we are powerless to protect them with the polysaccharide vaccines. The filing of this new vaccine is good news for African infants because it means that state of the art vaccine technology is now one step closer to those who need it,” continued Dr. Hodgson. “The arrival of Globorix™and other new conjugate vaccines is the start of a new era in meningococcal disease control for Africa.”


Meningococcal meningitis is a highly contagious infection caused by the bacterium Neisseria meningitidis. The bacteria are transmitted through respiratory secretions, such as sneezing or coughing, and direct contact with infected people. Without treatment, the mortality rate can go up to 50%2, with most deaths occurring only 24-48 hours after the appearance of symptoms. Africa’s “meningitis belt” encompasses 21 countries in sub-Saharan Africa and is home to more than 400 million people. Endemic meningitis infects children year-round and large outbreaks routinely occur during the dry season – between December and June – and major epidemics occur in cycles, every 8 – 12 years. The largest recorded outbreak took place in 1996 when 250,000 people contracted the disease and 25,000 died2.


Globorix™is intended for use in African meningitis belt countries, the Middle-East and Northern Africa, where it could replace the pentavalent combination vaccine (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b) already administered to many children. The new vaccine has been designed to fit with the Expanded Programme on Immunisation (EPI) calendar of organized infant immunization campaigns in Africa, which makes it an attractive and relevant public health response to a devastating disease in Africa.


GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals (GSK Biologicals) is one of the world’s leading vaccine manufacturers. The company is located in Rixensart (Belgium) and is the centre of all GlaxoSmithKline’s activities in the field of vaccine research, development and production. GSK Biologicals employs over 5 000 people in Belgium (over 8 000 worldwide), of whom more than 1 500 are passionate scientists devoted to discovering innovative vaccines and developing cost-effective and convenient combination products that contribute to the health and well-being of billions of people, in every generation around the world.


In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the world’s children up to six diseases in one vaccine.


GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.